Millions of Americans experience some degree of alopecia, commonly referred to as “balding” or simply “hair loss”, resulting in ever-increasing amounts of money being spent in efforts to stop the loss and/or grow the hair back.
Countless pharmaceutical remedies, cosmetic treatments, and surgical methods of varying success have been devised in order to address the problem of hair loss. The difficulty in identifying effective treatments stems from the fact that there is no one cause for hair loss, but rather, there are many, such as: hormonal changes, heredity, disease, stress, medications, infections, genetic disorders, toxic agents, and/or food deficiencies.
The majority of cases are hormonal in origin, for example—androgenic alopecia (also known as male-pattern alopecia and androgenetic alopecia), which is a distressing problem for a large proportion of adult men. This male balding most often starts between the ages of 30-50 years old. Occasionally, it may begin at an even younger age.
In men developing androgenic alopecia, there is a gradual atrophy of hair follicles due to a genetically-inherited sensitivity to 5α-dihydrotestosterone (also know as “dihydrotestosterone” or “DHT”). The enzyme 5-α-reductase transforms testosterone into dihydrotestosterone in the hair follicles, which then directs follicles to progressively shrink and finally disappear. Thus, considering that 5α-dihydrotestosterone is a key contributing factor to the onset and progression of androgenic alopecia, blocking DHT is an area of interest for protecting hair.
Although there are currently many accepted oral and topical treatments for balding, only two drugs have been approved by the Food and Drug Administration (FDA) to treat alopecia; topical minoxidil (trademark name—Rogaine®) and oral finasteride (trademark name—Propecia®).
Minoxidil, (trademark name—Rogaine®), was originally developed as a treatment for individuals with high blood pressure. While treating these individuals, it was discovered that minoxidil moderately increased hair growth and prevented future hair loss. It is also believed that minoxidil may increase hair growth in thinning hair areas, but the mechanism of action (of minoxidil) remains unknown.
However, although these advantages of use exist, there are problems associated with the use of minoxidil. The most common side effect of topical minoxidil is skin irritation and/or a local allergic reaction called contact dermatitis. Additionally, if the medication is stopped after prolonged use, hair loss may actually increase rather than decrease. Further, major complications of minoxidil are rare, but possible, and can include decreased blood pressure with headache, fatigue, and dizziness. Patients who suffer from heart disease or hypertension cannot utilize minoxidil without medical supervision.
Minoxidil in lower concentration is a non-prescription product currently sold over-the-counter in multiple different formulations for treatment of hair loss in both men and women.
The second FDA-approved drug is finasteride (trademark name—Propecia®). Finasteride was originally used to treat prostate enlargement by inhibiting the 5-α reductase enzyme. The inhibition of the 5-α reductase enzyme interferes with the formation of DHT by blocking the action of 5-α reductase on testosterone. Men undergoing this treatment experienced an increase in hair growth. It is believed that the inhibition of the 5-α reductase enzyme may increase hair follicle growth or prevent future hair follicle loss.
However, although these advantages of use exist, there are also problems associated with the use of finasteride. Men may experience decreased libido, decreased volume of ejaculate, and a lowered level of prostate specific antigen (PSA). This lowered level of PSA may interfere with screening for prostate cancer.
Further, pregnant or nursing women may not use finasteride because it is teratogenic, and can harm the human fetus. Due to such a serious health risk, finasteride has been limited to use within male patient populations only, leaving a majority of female alopecia sufferers to seek alternative treatment options.
A topical treatment for androgenic alopecia will have lower internal exposure leading to a lower internal side effect profile than oral medications such as finasteride. Currently available topical medications, i.e. minoxidil, have not worked consistently or effectively for balding. In theory, topical medications targeted at interfering with the production of testosterone derivatives or blocking the effects of dihydrotestosterone on its receptor (stopping the trigger of male-pattern hair loss) would be beneficial, but to date, none have been satisfactorily successful.
For additional background information regarding hair loss/alopecia, see U.S. Pat. Nos. 6,878,145 B2; 7,713,557 B2; and 8,080,524 B2.
Citation or identification of any reference/document in the instant application is not and should not be interpreted as an admission that such reference/documents is available as prior art to the present invention.